- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00283452
Keep Active Minnesota
Maintaining Physical Activity in Older Adult MCO Members
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The benefits of physical activity for adults are well established, but less than one-third of older adults in the U.S. have achieved recommended levels of physical activity despite widespread clinical recommendations to increase physical activity in recent years. Clinic-based approaches to increasing physical activity are expensive, difficult to implement in busy practice settings, and have limited reach. Moreover, evidence of the efficacy of such approaches is equivocal. A population based approach may be a more effective and less costly strategy to increase levels of physical activity in older adults. Population studies of physical activity have demonstrated that each year, many sedentary older adults initiate physical activity, but a nearly equal number of those who were active become sedentary. Among older adults initiating physical activity, only half continue to be active 3 months later.
We hypothesize that a population based approach that emphasizes physical activity maintenance can substantially increase physical activity levels in a defined populations of older adults. This hypothesis is tested in a 24-month randomized trial evaluating an innovative, theory-based behavioral intervention to maintain physical activity in a random sample of 50-70 year old adults who have recently become at least moderately active. One thousand (1000) subjects will be randomized to one of two experimental groups: 1) a "usual care" control group, and 2) an interactive phone- and mail-based intervention program tailored to maintaining physical activity in older adults. The primary outcome measures are: 1) physical activity, assessed as kcals/wk expenditure; and 2) physical activity maintenance, assessed as follow-up kcals/wk expenditure relative to baseline. Careful measurement of the penetration of the intervention into a well characterized older adult population, and the costs of the intervention, will be assessed. Psychosocial and behavioral mediators of physical activity maintenance will also be examined.
Study results will be relevant to policy makers, health promotion practitioners and health plans, and will provide practical information on the effectiveness, population penetration, and costs of an intervention designed to maximize population levels of physical activity among older adults.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Bloomington, Minnesota, United States, 55426
- HealthPartners Research Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults between the ages of 50 and 70;
- Have HealthPartners insurance for 11 out of the past 12 months;
- Engage in moderate physical activity for a total of 30 minutes at least two days per week;
- Have increased activity level in the past year.
Exclusion Criteria:
- Modified Charlson scores >=3 (calculated using prior year diagnoses);
- Nonskin cancer;
- Congestive heart failure;
- Coronary heart disease;
- Psychotic Illness;
- Substance abuse;
- Terminal illness.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
Participation in phone/mail-based intervention to maintain physical activity.
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Participation in phone/mail counseling to maintain physical activity
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No Intervention: Control
No intervention; participation in surveys only
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Absolute level of physical activity:
Time Frame: Assessed at baseline, 6, 12 and 24-month follow-up as kcals/wk expenditure based on survey self-report, validated against activity monitor data in a random sub-sample.
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Assessed at baseline, 6, 12 and 24-month follow-up as kcals/wk expenditure based on survey self-report, validated against activity monitor data in a random sub-sample.
|
Maintenance of physical activity
Time Frame: Physical activity level relative to baseline assessed at all follow-ups 6, 12, 24 months.
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Physical activity level relative to baseline assessed at all follow-ups 6, 12, 24 months.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Population penetration: Proportion of those eligible who agree to join the study, and proportion of those randomized to the intervention condition who complete the intervention protocol.
Time Frame: Final endpoint - 24 months
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Final endpoint - 24 months
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Mediating factors
Time Frame: Level of physical activity self-efficacy, social support for physical activity, and perceived benefits and barriers to activity will also be assessed at baseline and the 6, 12 and 24-month follow-ups.
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Level of physical activity self-efficacy, social support for physical activity, and perceived benefits and barriers to activity will also be assessed at baseline and the 6, 12 and 24-month follow-ups.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Brian C. Martinson, PhD, HealthPartners Institute
Publications and helpful links
General Publications
- Senso MM, Anderson CP, Crain AL, Sherwood NE, Martinson BC. Self-reported activity and accelerometry in 2 behavior-maintenance trials. Am J Health Behav. 2014 Mar;38(2):254-64. doi: 10.5993/AJHB.38.2.11.
- Sherwood NE, Martinson BC, Crain AL, Hayes MG, Pronk NP, O'Connor PJ. A new approach to physical activity maintenance: rationale, design, and baseline data from the Keep Active Minnesota Trial. BMC Geriatr. 2008 Jul 25;8:17. doi: 10.1186/1471-2318-8-17.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 03-024
- 1R01AG023410-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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